ILARecalls & reported problems across all models

We found 5 models of ILA by Covidien LP in the FDA's device registry (GUDID). Together they are named in 93 adverse event reports in the FDA's MAUDE database, received between Aug 2, 2017 and Apr 13, 2021 — classified as 14 injuries, 79 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (45 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ILA problems

ILA models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ILA 3948L

  STAPLE, IMPLANTABLE
  54 reports
• ILA 3971

  STAPLE, IMPLANTABLE
  25 reports
• ILA 3957

  STAPLE, IMPLANTABLE
  8 reports
• ILA 3973

  STAPLE, IMPLANTABLE
  4 reports
• ILA 3975

  STAPLE, IMPLANTABLE
  2 reports

Recent ILA adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2021Break; Failure to Cut; Break; Failure to Cut

  ACCORDING TO THE REPORTER, DURING OPEN ABDOMINAL SURGERY, THE TISSUE WAS STAPLED, BUT THE CUTTER DID NOT MOVE WELL. THE DEVICE BROKE AND THE CUTTER GOT DAMAGED. IT WAS CUT WITH ELECTROSURGICAL KNIFE TO SOLVE THE PROBLEM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11656876 ↗
• InjuryAug 28, 2020Misfire; Failure to Form Staple; Misfire; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING THE TRANSECTION OF THE TISSUE ON A J-POUCH SURGERY, AFTER FIRING THE SURGEON NOTICED AN INCOMPLETE STAPLE LINE AND POOR STAPLE FORMATION. THE SURGEON OVERSEW THE STAPLE LINE TO RESOLVE THE ISSUE. IT WAS NOTICED THAT THE STAPLER HAD NOT BEEN LOADED PROPERLY BY THE SCRUB TECHNICIAN.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 10469222 ↗
• MalfunctionJun 17, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING COLON SURGERY, WHEN ON A FUNCTIONAL SIDE-TO-SIDE ANASTOMOSIS, THE DEVICE WAS UNABLE TO BE FIRED. WHEN A NEW CARTRIDGE WAS ATTACHED, IT WAS ABLE TO BE FIRED WITHOUT PROBLEM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10163271 ↗
• MalfunctionMay 13, 2020Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, DURING COLECTOMY, THE STAPLE WAS FIRED, BUT THE TISSUE WAS NOTED NOT BEING CUT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10050273 ↗
• InjuryApr 5, 2020Product Quality Problem; Failure to Fire; Product Quality Problem; Failure to Fire

  ACCORDING TO THE REPORTER, DURING COLECTOMY, THE RELOAD WAS SEEN TO BE CURVED THAT MADE THE KNIFE UNABLE TO SLIDE AND BLOCKED. THE PROCEDURE WAS CONVERTED TO OPEN COLECTOMY.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 9927095 ↗
• MalfunctionMar 23, 2020Material Separation; Misfire; Failure to Cut; Material Separation; Misfire; Failure to Cut

  ACCORDING TO THE REPORTER, DURING A DISTAL GASTRECTOMY, THE CARTRIDGE WAS ATTACHED TO THE STAPLER, AND WHEN AN ATTEMPT WAS MADE TO FIRE THE DEVICE ON THE STOMACH, THE STAPLES CAME OUT BY FIRING, THE KNIFE WAS NOT PUSHED OUT. THE DEVICE COULD NOT BE USED. AS FAR AS THE SAMPLE WAS SEEN, MOST OF THE STAPLES HAVE BEEN FIRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN THIRTY MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9864198 ↗
• MalfunctionMar 17, 2020Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING DISTAL GASTRECTOMY, THE DEVICE STOPPED WORKING IN THE MIDDLE OF THE PROCEDURE AT THE TIME OF FIRING. IT WAS NOTED THAT SURGICAL TIME WAS EXTENDED LESS THAT FIVE MINUTES. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Information

  MAUDE report 9842985 ↗
• MalfunctionJan 20, 2020Failure to Cut; Material Twisted/Bent; Failure to Cut; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING PROXIMAL GASTRECTOMY, WHEN USING THE LOADING UNIT, IT WAS TOO STIFF AND THE KNIFE DID NOT MOVE. THE SURGEON TRIED TO FIRE ON NOTHING WITHOUT TISSUE CLAMPED, BUT THE KNIFE STILL DID NOT MOVE AT ALL. WHEN USING ANOTHER LOADING UNIT, THE KNIFE BENT AND COULD NOT CUT AT ALL HOWEVER, THE STAPLES HAVE BEEN PROPERLY FORMED UNTIL THE END. THEY WERE NOT ABLE TO CUT WITH THE KNIFE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9607256 ↗
• MalfunctionJan 20, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING PROXIMAL GASTRECTOMY, WHEN USING THE LOADING UNIT, IT WAS TOO STIFF AND THE KNIFE DID NOT MOVE. THE SURGEON TRIED TO FIRE ON NOTHING WITHOUT TISSUE CLAMPED, BUT THE KNIFE STILL DID NOT MOVE AT ALL. WHEN USING ANOTHER LOADING UNIT, THE KNIFE BENT AND COULD NOT CUT AT ALL HOWEVER, THE STAPLES HAVE BEEN PROPERLY FORMED UNTIL THE END. THEY WERE NOT ABLE TO CUT WITH THE KNIFE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9607222 ↗
• MalfunctionDec 30, 2019Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER DURING CLOSURE OF THE ANASTOMOSES IN A LAPAROSCOPIC RIGHT HEMICOLECTOMY PROCEDURE, THERE WAS POOR STAPLE FORMATION. THE STAPLE LINE ON THE TISSUE THAT WAS LEFT IN THE PATIENT'S CAVITY LOOKED GOOD, BUT THE STAPLE LINE ON THE SPECIMEN THAT WAS EXPLANTED WAS MALFORMED. THE STAPLES DID NOT APPEAR TO HAVE HIT THE ANVIL BUCKETS. THE STAPLE LEGS WERE STRAIGHT WITH NO SIGN OF B-FORMATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9530252 ↗
• InjuryDec 30, 2019Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ASSISTED RIGHT HEMICOLECTOMY PROCEDURE, ON THE SECOND FIRING TO CLOSE THE ANASTOMOSIS, ONE ROW OF THE STAPLES FORMED BUT THE SECOND ROW OF THE STAPLES PARTIALLY FORMED THE LAST 1/3 OF THE STAPLE LINE. THE STAPLE LINE WAS FIXED BY OVERSEWING.

  Patient problems: No Code Available

  MAUDE report 9530116 ↗
• MalfunctionDec 6, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, ON A COLECTOMY END-TO-END ANASTOMOSIS, DURING THE FIRST FIRING, DESPITE OPERATING THE KNOB, THE KNOB DID NOT MOVE FORWARD AND THE DEVICE COULD NOT FIRE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9424908 ↗
• InjuryNov 25, 2019Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC RIGHT COLON RESECTION, WHILE CLOSING THE ANASTOMOSIS, THE FORMATION OF THE STAPLES DISTALLY WAS POOR. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THE STAPLE LINE WAS OVER-SEWN, RESECTED, AND RESTAPLED.

  Patient problems: No Code Available

  MAUDE report 9368750 ↗
• MalfunctionOct 28, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A SMALL INTESTINE RESECTION PROCEDURE, WHILE USING THE DEVICE FOR SMALL INTESTINE RESECTION, BUT THE FIRING KNOB DID NOT MOVE FORWARD. THE DEVICE WAS ABLE TO BE FIRED AFTER THE RELOAD WAS REPLACED WITH A NEW ONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9247894 ↗
• MalfunctionOct 8, 2019Material Twisted/Bent; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING COLOSTOMY, THE KNIFE BAR BENT WHILE FIRING. IT WAS STATED THAT THE ISSUE OCCURRED SUCCESSIVELY IN 3 UNITS. THE JAWS CLAMPING THE SIGMOID COLON OF THE PATIENT WERE OPENED AND THE RELOAD WAS REPLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9166858 ↗

Other Covidien LP products

• Endo GIA48 models · 26,277 reports · 8 recalls
• Endo GIA Ultra3 models · 15,650 reports
• Shiley387 models · 9,392 reports · 5 recalls
• Signia16 models · 8,201 reports · 6 recalls
• LigaSure32 models · 7,283 reports · 1 recall
• Tri-Staple 2.037 models · 4,892 reports · 2 recalls
• Polysorb291 models · 4,564 reports · 2 recalls
• EEA39 models · 4,432 reports · 1 recall